Status
Terminated
Drug Enforcement D-0617-2024
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Classification
Class II
Report Date
July 31, 2024
Termination Date
August 6, 2025
Product Information
- Product description
- Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
- Product quantity
- a) 13,128 bottles; b) 252 bottles
- Reason for recall
- Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Address
-
73 Route 31 N
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0617-2024
- Event ID
- 94850
- Recall initiation date
- June 21, 2024
- Center classification date
- July 23, 2024
- Code info
- Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
- More code info
- —